Reperfusion InjuryNCT02512640
Comparison of Oxidative Stress Changes in Different Ventilation Strategies During Gynecologic Laparoscopic Surgery
A study of Reperfusion Injury and Oxidative Stress, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Ischemia-reperfusion injury resulted from pneumoperitoneum during laparoscopic surgery have been reported in some literatures. There are no studies investigating the time course of changes in oxidative stress markers in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) modes. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reperfusion Injury, Oxidative Stress
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 20 and 70 years with a BMI < 30 kg/m2 scheduled for laparoscopic gynecologic surgery requiring at least 1 hour of pneumoperitoneum
Who cannot join
- cardiopulmonary disease and a history of sepsis or shock, findings suspicious of malignant disease, previous major abdominal operation, smoking, and recent antioxidant use (i.e. vitamins A, C and E).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
About this study
Ischemia-reperfusion injury resulted from pneumoperitoneum during laparoscopic surgery have been reported in some literatures. There are no studies investigating the time course of changes in oxidative stress markers in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) modes. The aim of this study is to compare the alterations in oxidative stress in two different ventilation strategies during gynecologic laparoscopic surgery.
Methods:
Fifty-two patients of ASA physical status I or II were randomly assigned to receive either VCV or PCV during laparoscopic gynecologic surgery. Blood gas analysis and ventilation variables were recorded 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum. Blood samples for malondialdehyde (MDA) measurement were collected at seven points: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; 30 minutes, 60 minutes, 90 minutes, and 120 minutes after deflation (T3~T6); and 24 hours after deflation (T7).
Read the detailed description
Pneumoperitoneum during laparoscopic procedures greatly impairs splanchnic blood flow due to compression. Increased intra-abdominal pressure may elevate the diaphragm, increase intra-thoracic pressure, reduce functional residual capacity, and thus lead to atelectasis. In a collapsed lung, blood flow is decreased and reperfusion injury may subsequently occur during re-expansion of the lung. This ischemia-reperfusion injury results from the formation of reactive oxygen species (ROS), which are highly reactive intermediates of the oxygen metabolism. When there is an imbalance between ROS generation and removal by antioxidative mechanisms, oxidative stress occurs and eventually causes cellular and organ damage. Oxidative stress mediates tissue injury and may represent an important link between laparoscopy and clinical side effects. Malondialdehyde (MDA) is considered the most reliable marker of oxidative stress in the clinical setting. It is a breakdown product of lipid peroxidation in tissues. An elevated concentration of MDA reflects the level of lipid peroxidation.
Although there is abundant data comparing the effects of VCV and PCV during laparoscopic surgery, the time course of changes in oxidative stress in these two modes has not been elucidated. Therefore, the aim of this study was to compare the alterations of oxidative stress in two different ventilation modes, VCV and PCV, during gynecologic laparoscopic surgery. To this end, the investigators established a prospective randomized clinical study and measured the plasma levels of a lipid peroxidation marker at different stages.
Fifty-two patients of ASA physical status I or II were randomly assigned to receive either VCV or PCV during laparoscopic gynecologic surgery. During the operation, blood gas analysis and ventilation variables were recorded 1 minute before (T1) and 1 hour after (T2) the establishment of CO2 pneumoperitoneum in both groups. Blood samples for MDA measurement were collected at seven points: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; at intervals of 30 minutes for 2 hours after the deflation of CO2 (T3~T6); and 24 hours after the deflation of CO2 (T7). The samples were immediately centrifuged (1000g, 10 minutes) and the supernatants were stored at -800C until further analysis, which took place within 1 week. The investigators assessed the quality of recovery from anesthesia using a nine-item quality of recovery score (QoR Score) before operation and 24 hours after the deflation of CO2.
- Conditions
- Reperfusion Injury, Oxidative Stress
- Being tested
- Volume-controlled ventilation, Pressure-controlled ventilation
- Keywords
- Pressure-controlled ventilation, Volume-controlled ventilation, Laparoscopy, Oxidative stress
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-controlled ventilationProcedure or surgery
a tidal volume of 8 ml/kg
Pressure-controlled ventilationProcedure or surgery
a peak airway pressure to maintain a tidal volume of 8 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Volume-controlled ventilation | Active comparator | Volume-controlled ventilation throughout the surgery Receives: Procedure: Volume-controlled ventilation |
| Pressure-controlled ventilation | Active comparator | Pressure-controlled ventilation throughout the surgery Receives: Procedure: Pressure-controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak airway pressure
During surgery, CO2 pneumoperitoneum was induced with an intraabdominal pressure of 15 mmHg. After one hour of pneumoperitoneum, ventilation variables were recorded.
Measured: 1 hour after the establishment of CO2 pneumoperitoneum
Secondary outcomes (1)
plasma MDA concentration
Measured: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; at intervals of 30 minutes for 2 hours after the deflation of CO2 (T3~T6); and 24 hours after the deflation of CO2 (T7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Chih Liao, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512640
- Sponsor's protocol ID
- CGMH-IRB-102-0112A3
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sammour T, Mittal A, Loveday BP, Kahokehr A, Phillips AR, Windsor JA, Hill AG. Systematic review of oxidative stress associated with pneumoperitoneum. Br J Surg. 2009 Aug;96(8):836-50. doi: 10.1002/bjs.6651.
PubMed 19591166Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.
PubMed 16054557Kontoulis TM, Pissas DG, Pavlidis TE, Pissas GG, Lalountas MA, Koliakos G, Topouridou K, Sakantamis AK. The oxidative effect of prolonged CO(2) pneumoperitoneum a comparative study in rats. J Surg Res. 2012 Jun 15;175(2):259-64. doi: 10.1016/j.jss.2011.09.030. Epub 2011 Oct 12.
PubMed 22172128
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxidative Stress Changes in Different Ventilation Strategies During Gynecologic Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02512640
- Acronym / sponsor ID
- CGMH-IRB-102-0112A3
- Conditions
- Reperfusion Injury, Oxidative Stress
- Keywords
- Pressure-controlled ventilation, Volume-controlled ventilation, Laparoscopy, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ischemia-reperfusion injury resulted from pneumoperitoneum during laparoscopic surgery have been reported in some literatures. There are no studies investigating the time course of changes in oxidative stress markers in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) modes. The aim of this study is to compare the alterations in oxidative stress in two different ventilation strategies during gynecologic laparoscopic surgery.
Methods:
Fifty-two patients of ASA physical status I or II were randomly assigned to receive either VCV or PCV during laparoscopic gynecologic surgery. Blood gas analysis and ventilation variables were recorded 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum. Blood samples for malondialdehyde (MDA) measurement were collected at seven points: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; 30 minutes, 60 minutes, 90 minutes, and 120 minutes after deflation (T3~T6); and 24 hours after deflation (T7).
Detailed description
Pneumoperitoneum during laparoscopic procedures greatly impairs splanchnic blood flow due to compression. Increased intra-abdominal pressure may elevate the diaphragm, increase intra-thoracic pressure, reduce functional residual capacity, and thus lead to atelectasis. In a collapsed lung, blood flow is decreased and reperfusion injury may subsequently occur during re-expansion of the lung. This ischemia-reperfusion injury results from the formation of reactive oxygen species (ROS), which are highly reactive intermediates of the oxygen metabolism. When there is an imbalance between ROS generation and removal by antioxidative mechanisms, oxidative stress occurs and eventually causes cellular and organ damage. Oxidative stress mediates tissue injury and may represent an important link between laparoscopy and clinical side effects. Malondialdehyde (MDA) is considered the most reliable marker of oxidative stress in the clinical setting. It is a breakdown product of lipid peroxidation in tissues. An elevated concentration of MDA reflects the level of lipid peroxidation.
Although there is abundant data comparing the effects of VCV and PCV during laparoscopic surgery, the time course of changes in oxidative stress in these two modes has not been elucidated. Therefore, the aim of this study was to compare the alterations of oxidative stress in two different ventilation modes, VCV and PCV, during gynecologic laparoscopic surgery. To this end, the investigators established a prospective randomized clinical study and measured the plasma levels of a lipid peroxidation marker at different stages.
Fifty-two patients of ASA physical status I or II were randomly assigned to receive either VCV or PCV during laparoscopic gynecologic surgery. During the operation, blood gas analysis and ventilation variables were recorded 1 minute before (T1) and 1 hour after (T2) the establishment of CO2 pneumoperitoneum in both groups. Blood samples for MDA measurement were collected at seven points: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; at intervals of 30 minutes for 2 hours after the deflation of CO2 (T3~T6); and 24 hours after the deflation of CO2 (T7). The samples were immediately centrifuged (1000g, 10 minutes) and the supernatants were stored at -800C until further analysis, which took place within 1 week. The investigators assessed the quality of recovery from anesthesia using a nine-item quality of recovery score (QoR Score) before operation and 24 hours after the deflation of CO2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volume-controlled ventilation | Active comparator | Procedure: Volume-controlled ventilationVolume-controlled ventilation throughout the surgery |
| Pressure-controlled ventilation | Active comparator | Procedure: Pressure-controlled ventilationPressure-controlled ventilation throughout the surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 20 and 70 years with a BMI < 30 kg/m2 scheduled for laparoscopic gynecologic surgery requiring at least 1 hour of pneumoperitoneum
Key exclusion criteria (1 listed)
- cardiopulmonary disease and a history of sepsis or shock, findings suspicious of malignant disease, previous major abdominal operation, smoking, and recent antioxidant use (i.e. vitamins A, C and E).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume-controlled ventilationa tidal volume of 8 ml/kg | Procedure or surgery | Volume-controlled ventilation |
| Pressure-controlled ventilationa peak airway pressure to maintain a tidal volume of 8 ml/kg | Procedure or surgery | Pressure-controlled ventilation |
Primary outcome
peak airway pressure
Time frame: 1 hour after the establishment of CO2 pneumoperitoneum
During surgery, CO2 pneumoperitoneum was induced with an intraabdominal pressure of 15 mmHg. After one hour of pneumoperitoneum, ventilation variables were recorded.
1 secondary outcome
plasma MDA concentration
Time frame: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; at intervals of 30 minutes for 2 hours after the deflation of CO2 (T3~T6); and 24 hours after the deflation of CO2 (T7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Background: PubMed 19591166Sammour T, Mittal A, Loveday BP, Kahokehr A, Phillips AR, Windsor JA, Hill AG. Systematic review of oxidative stress associated with pneumoperitoneum. Br J Surg. 2009 Aug;96(8):836-50. doi: 10.1002/bjs.6651.
- Background: PubMed 16054557Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.
- Background: PubMed 22172128Kontoulis TM, Pissas DG, Pavlidis TE, Pissas GG, Lalountas MA, Koliakos G, Topouridou K, Sakantamis AK. The oxidative effect of prolonged CO(2) pneumoperitoneum a comparative study in rats. J Surg Res. 2012 Jun 15;175(2):259-64. doi: 10.1016/j.jss.2011.09.030. Epub 2011 Oct 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Chih Liao, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Reperfusion Injury and Oxidative Stress, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak airway pressure (time frame: 1 hour after the establishment of CO2 pneumoperitoneum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512640, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.